Services

EU/GB Representation

BPR Representation

Both the EU and new GB Biocidal Products Regulation (BPR) currently follow the same principles.

 

The BPR applies to 22 product types assigned to four main groups:

  • Disinfectants for home and industrial use

  • Preservatives for manufactured and natural products

  • Pest control products

  • Other specialist biocidal products such as antifouling agents

Access to the market is based on a two-step procedure:

  • The active substance to be used in a biocidal product or to treat an article must be approved (assessed positively for its efficacy and safety in the relevant product type at EU level, or in the case of GB BPR, by the Standing Committee).

  • The biocidal product requires an authorisation at national or EU level before it can be made available on the market or used

  • If the active substance is not yet approved but is in the Review Programme, the biocidal product can be made available and used in accordance with national laws

Arrow Regulatory have extensive experience in management of active substances and biocidal products. Please contact us for further discussion.

Active substances

An active substance can be used in a biocidal product for the EEA/GB market if it complies with one of the following conditions:

  • It is approved for the specific product type in which it is used.

  • It is included in the list of substances that do not give rise to concern for health and the environment (Annex I of the BPR)

  • It is an existing active substance (already on the market on 14 May 2000) and is in the Review Programme

  • From 01 September 2015, no biocidal products can be made available on the market unless either the active substance supplier or the product supplier is included on the Article 95 list of active substances and suppliers. 

EU BPR: Non-EU companies can be represented by an EU Representative, for the purpose of Article 95, and can be indicated on the list next to their EU Representative. 


GB BPR: Non-GB companies can be represented by a GB Representative, for the purpose of Article 95, and can be indicated on the list next to their GB Representative 
 

Please contact us for details of how Arrow Regulatory can assist with this aspect of active substance compliance.

Biocidal Products

After the biocidal active substance has been approved, or included on the list of substances which do not give rise to concern (Annex I of the BPR), a biocidal product containing it must be authorised before it can be made available on the European Economic Area (EEA)/GB market:

  • The authorisation holder is responsible for the placing of the product on the market (its first supply for distribution or use in the EEA/GB). This includes responsibility for the correct classification (according to the CLP Regulation) together with packaging and labelling of the product.

  • The authorisation holder is also obliged to inform the competent authorities of information that may affect the product authorisation, for example information about safety.

  • The authorisation holder must be a natural or legal person established in the EEA for EU BPR and GB for GB BPR and can be the manufacturer, importer or a consultant

 

Please contact us for discussion of Arrow Regulatory's proficiency when acting as authorisation holder.

EU REACH Only Representation

Manufacturers, formulators and producers of articles, who are based outside the European Economic Area, can appoint a European-based Only Representative (OR) to take over the REACH compliance responsibilities of EU importers for named substances. These importers are then regarded as downstream users.

Only Representative functions met by Arrow Regulatory (Ireland​) Ltd.:

  • Compliance with REACH Article 8

  • Permanent physical presence of experienced personnel in the EU

  • Clear understanding of REACH and associated regulatory and administration procedures

  • Substantial experience of complex supply chains

  • Competence in handling volumes of confidential information

 

The team at Arrow Regulatory have substantial experience in the role of Only Representative. Please contact us for further discussion.

Arrow Regulatory Limited

6th Floor, East West Building

2 Tollhouse Hill

Nottingham NG1 5FS

UNITED KINGDOM
 

T: +44 (0) 115 9352243

Arrow Regulatory (Ireland) Limited

9 Pembroke Street Upper
Dublin 2

D02 KR83

IRELAND


T:  +353 (0) 1 653 2165

Arrow Regulatory GmbH

Grabenweg 68

6020 Innsbruck

Tyrol

AUSTRIA


T:  +43 (0) 660 1162392   

linkedin
twiter

© 2021 Arrow Regulatory

Arrow Regulatory Limited is a company registered in England and Wales with company number 10171397. Registered Office: 149-155 Canal Street, Nottingham,  NG1 7HR, UK

Arrow Regulatory (Ireland) Limited is a company registered in Ireland with company number 614017. Registered Office: The Black Church, St Mary's Place, Dublin 7, D07 P4AX, Ireland

Arrow Regulatory GmbH is a company registered in Austria with a company number FN 529473m. Registered Office: Grabenweg 68, 6020 Innsbruck, Tyrol, Austria  [Impressum]